Effect of an Apple Polyphenol Extract on Brachial Artery Flow-mediated Vasodilatory Function

April 7, 2014 updated by: Danisco

The Effect of an Apple Polyphenol Extract Rich in Epicatechin and Flavan-3-ol Oligomers (Evesse™ EPC) on Brachial Artery Flow-mediated Vasodilatory Function (FMD)in Volunteer Subjects

Effect of apple polyphenols on FMD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover study is to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves brachial artery endothelium-dependent vasodilation function (FMD) in volunteer subjects with borderline hypertension. FMD and endothelium-independent nitrate-mediated vasodilatation (NMD) of the left brachial artery will be investigated with ultrasonography at the start and end of both treatment periods. Biomarkers of vascular function and epicatechin (and metabolite) concentrations will be determined from blood samples taken at the start and end of both treatment periods. Diet diary data will be collected for the evaluation of the possible effects of diet on the study results. Adverse events data will be collected throughout the study. Safety laboratory determinations will be performed at the last visit of both treatment periods.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • University of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Borderline hypertension
  • Otherwise healthy
  • Aged 40-65 years (inclusive)
  • Not consuming high amounts (over 20 mg daily) of flavonoids

Exclusion Criteria:

  • BMI >32 kg/m2
  • Total serum cholesterol ≥ 8 mmol/l
  • Any abnormal safety laboratory parameter or abnormal finding in ECG evaluated to be clinically significant
  • Coronary artery disease
  • Pregnancy or lactating
  • Alcohol abuse as evaluated by medical history
  • Regular smoking/using nicotine products
  • Diabetes mellitus
  • Apple allergy
  • Use of lipid lowering medications
  • Regular use of any medication that is known or believed to affect endothelial function or blood vessel constriction
  • Any other condition or medication that in the opinion of the investigator would interfere with the evaluation of the study results or constitute a health risk for the subject
  • High consumption of vitamin products, herbal remedies or products containing flavonoids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Epicatechin
The subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods.
Dietary supplement: Epicatechin
Placebo Comparator: Microcrystalline cellulose
The subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods.
Dietary supplement: Microcrystalline cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brachial flow-mediated dilation test (FMD)
Time Frame: At first visits of both periods baseline FMD will be recorded followed by FMD recording 1.5 hours after first dose. After 4 weeks intervention, at last visits of both periods FMD will be recorded, last dose will be taken and FMD recorded 1.5 hours after.
ultrasonography, FMDmax%
At first visits of both periods baseline FMD will be recorded followed by FMD recording 1.5 hours after first dose. After 4 weeks intervention, at last visits of both periods FMD will be recorded, last dose will be taken and FMD recorded 1.5 hours after.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nitrate-mediated vasodilatation response (NMD)
Time Frame: At the first and last visits of both periods, approximately 10 minutes after FMD.
ultrasonography, NMDmax%
At the first and last visits of both periods, approximately 10 minutes after FMD.
Circulating biomarkers of vascular function
Time Frame: Once at the first visit of both periods and once at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter
depends on the biomarker
Once at the first visit of both periods and once at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter
BP
Time Frame: Once at the first visit of both periods and once at the last visit of both periods. Blood pressure will be recorded twice prior to the morning dose.
Once at the first visit of both periods and once at the last visit of both periods. Blood pressure will be recorded twice prior to the morning dose.
Plasma epicatechin concentration
Time Frame: At the first visit of both periods and at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter
HPLC
At the first visit of both periods and at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danisco

Collaborators

University of Turku
4Pharma Ltd.

Investigators

  • Study Director: Kirsti Tiihonen, PhD, Danisco
  • Principal Investigator: Olli Raitakari, MD, University of Turku, Turku, Finland, The Research Centre of Applied and Preventive Cardiovascular Medicine
  • Principal Investigator: Pia Salo, MD, PhD, University of Turku, Turku, Finland, The Research Centre of Applied and Preventive Cardiovascular Medicine
  • Principal Investigator: Anne Lithonius, Clinical Research Services Turku
  • Study Chair: Mika Scheinin, MD, PhD, Clinical Research Services Turku
  • Principal Investigator: Jari Turunen, MSc, 4Pharma Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimate)

September 24, 2012

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Epi2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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